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TerminatedNCT00364429Updated Jan 11, 2016

SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia

A Phase 1 interventional study of [123]I-CNS 1261 and Lorazepam in Schizophrenia, sponsored by GlaxoSmithKline. Terminated at 1 site in Spain. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-11.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Diagnostic

Why this study was terminated
terminated
Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before: Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).

02

Conditions studied

  • Schizophrenia

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Keywords

  • schizophrenic patients
  • SPET
  • NMDA receptor
  • ligand [123]I-CNS 1261
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 55 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Right-handed
  • Smoker
  • Healthy volunteer or schizophrenic patients as diagnosed by DSM IV criteria.
  • Treatment naive patients or with Risperidone treatment for 2 months that have not received any depot neuroleptic during the last year.
  • Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria

Exclusion criteria:

  • Any clinically or laboratory significant abnormality.
  • Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
  • Heart pacemaker, metallic prosthesis or other metallic body implants.
  • History or presence of CNS conditions.
  • History of substance dependence.
  • History of or suffers from claustrophobia.
  • Positive test for HBV (hepatitis B virus), HCV (hepatitis C virus) or HIV.
  • Pregnant or lactating women.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Interventions

  • Drug[123]I-CNS 1261

    Study Drug

  • DrugLorazepam

    Study Drug

  • DrugRisperidone

    Study Drug

    Also known as: [123]I-CNS 1261, Lorazepam

06

What researchers measure

Primary outcomes

  1. CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients.

    Time frame: throughout the study

Secondary outcomes

  1. Effect of treatment with risperidone and lorazepam in inducing changes on [123]I CNS 1261 binding, and its relationship with the plasma concentration of administered drugs and with Psychopathological scales scores.

    Time frame: throughout the study

07

Study locations

1 site
  • GSK Investigational Site
    Barcelona, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00364429
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 15, 2006
Start date
Jul 2005
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Jan 11, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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